Symbicort

• Inhalation medicine
• Used to treat asthma and COPD
• Reduces respiratory distress and coughing
• Prevents asthma symptoms from happening

Symbicort is an inhalation medicine. It contains two active ingredients:

• Formoterol. This medicine works by relaxing the muscles in your airways. This helps you breathe more easily. Formoterol belongs to a group of medicines called long-acting bèta 2‑adrenoceptor agonists.
• Budesonide. This anti-inflammatory medicine protects the lungs from asthma triggers. Budesonide belongs to a group of medicines called corticosteroids (adrenal cortex hormones).

Symbicort is prescribed by doctors to provide relief from symptoms of asthma and chronic obstructive pulmonary disease (COPD), such as chest tightness, wheezing and coughing. Symbicort can be used for relief of acute asthma symptoms and/or to prevent asthma symptoms from happening. The doctor will tell you how you need to use this medicine.

Symbicort is inhaled. To prevent asthma symptoms from happening, it is important to use Symbicort every day, even if you have no asthma symptoms at the time.

You can also use Symbicort to treat your symptoms when they happen. You doctor may also describe a different medicine to help manage your asthma.

There are various Symbicort inhalers, including the Turbohaler. See the package leaflet provided with Symbicort Turbohaler for step-by-step instructions on how to use this inhaler. Follow these instructions closely. The general guidelines for use are:

• Prepare your Turbohaler for use according to the instructions in the package leaflet.
• Remove the dustcap.
• Hold your Turbohaler upright with the red grip at the bottom.
• Do not hold the mouthpiece when you load your Turbohaler. To load your Turbohaler with a dose, turn the red grip as far as it will go in one direction. Then turn it as far as it will go in the other direction. You should hear a click sound. Your Turbohaler is now loaded and ready to use. Only load your Turbohaler when you need to use it.
• Breathe out gently as far as comfortable. (Do not breathe out through your Turbohaler.)
• Place the mouthpiece gently between your teeth. (Do not bite on the mouthpiece.) Close your lips. Breathe in as deeply and hard as you can through your mouth.
• Remove the Turbohaler from your mouth. Then breathe out gently (not through the mouthpiece).
• If you are to take a second inhalation, repeat the above steps.
• Rinse your mouth with water after the dose and spit it out. This will prevent irritation in your mouth and throat.
• Replace the cover by screwing it back on tightly after use.

Dosage

Symbicort is available in various strengths. Strength, the number of inhalations and inhalation frequency must be determined by a doctor.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

Used too much/forgot to take/stop taking Symbicort

It is important that you take your dose as advised by your doctor. If you use more Symbicort than prescribed, symptoms such as tremor, headache, rapid heartbeat may occur.

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten one.

Do not stop using Symbicort without consulting a doctor first.

Symbicort is not suitable for everyone. Do not use this Symbicort if you are allergic to any of the ingredients in this medicine (see section 'What Symbicort contains').

When should this medicine be used with caution?

Talk to your doctor before using Symbicort if:

• You have diabetes.
• You have a lung infection.
• You have high blood pressure or have ever had a heart problem (including an irregular heartbeat, a very fast pulse, narrowing of the arteries or heart failure).
• You have problems with your thyroid or adrenal glands.
• You have severe liver problems.
• You have low levels of potassium in your blood.

Pregnancy and breastfeeding

If you are pregnant or trying to conceive, talk to your doctor before using this medicine. Do not use this medicine unless your doctor tells you to.

If you get pregnant while using this medicine, do not stop using Symbicort but talk to your doctor immediately.

If you are breastfeeding, talk to your doctor before using this medicine.

Other medicines and Symbicort

Tell your doctor if you are taking any of these medicines:

• Beta-blocker medicines (e.g., atenolol or propranolol for high blood pressure), including eyedrops (e.g., timolol for glaucoma).
• Medicines for a fast or irregular heartbeat (e.g., quinidine).
• Medicines like digoxin, often used to treat heart failure.
• Diuretics, also known as water tablets, (e.g., furosemide).
• Steroid medicines that you take by mouth (e.g., prednisolone).
• Xanthine medicines (e.g., theophylline or aminophylline). These are often used to treat asthma.
• Other bronchodilators (e.g., salbutamol).
• Tricyclic antidepressants (e.g., amitriptyline) and the antidepressant nefazodone.
• Monoamine oxidase inhibitors, also known as MAOIs (e.g., phenelzine).
• Phenothiazine medicines to treat psychoses (e.g., chlorpromazine and prochlorperazine).
• Medicines called HIV-protease inhibitors (e.g., ritonavir) to treat HIV infection.
• Medicines to treat infections (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, claritromycin and telithromycin).
• Medicines for Parkinson's disease (e.g., levodopa).
• Medicines for thyroid problems (e.g., levothyroxine).

Please tell your doctor or pharmacist if you are taking or have recently taken any of these or other medicines, including herbal remedies and medicines obtained without a prescription.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or dental treatment.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Symbicort include:

Common (may affect up to 1 in 10 people):

• Palpitations, trembling or shaking. If these effects occur, they are usually mild and normally disappear as you continue to use your Symbicort Turbohaler.
• Fungal infection in the mouth (thrush). This is less likely if you rinse your mouth out with water after using your Symbicort Turbohaler.
• Mild sore throat, coughing and a hoarse voice.
• Headache.

Uncommon (may affect up to 1 in 100 people):

• Feeling restless, nervous or agitated.
• Disturbed sleep.
• Dizziness.
• Nausea (feeling sick).
• Palpitations (rapid heartbeat).
• Bruising of the skin.
• Muscle cramps.

Please refer to the package leaflet for a list of rare side effects, and side effects that may occur with prolonged use.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Get emergency medical help if you have signs of a severe allergic reaction (see the package leaflet).

The active substances in this medicine are budesonide and formoterol fumarate dihydrate. Each inhaled dose contains:

• Symbicort 100/6: 100 micrograms budesonide and 6 micrograms formoterol fumarate dihydrate.
• Symbicort 200/6: 200 micrograms budesonide and 6 micrograms formoterol fumarate dihydrate.
• Symbicort 400/12: 400 micrograms budesonide and 12 micrograms formoterol fumarate dihydrate.

The other ingredient in this medicine is lactose monohydrate (which contains milk proteins).

The manufacturers of Symbicort are:

AstraZeneca AB Kvarnbergagatan 12
SE-151 85 Södertälje
Sweden

AstraZeneca GmbH Tinsdaler Weg 183
D-22880 Wedel
Germany

AstraZeneca UK Ltd Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
United Kingdom

Read the package leaflet before use.